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Mouth Guard
EUDAMEDClass I (EU MDR)
Ref TW-T006Model TW-T001，TW-T002，TW-T003，TW-T004，TW-T005，TW-T006，TW-T007，TW-T008，TW-T009，TW-T010，TW-T011，TW-T012，TW-T013，TW-T014，TW-T015，TW-T016，TW-T017，TW-T018，TW-T019，TW-T020，or customized
Identity
- Device Name
- Mouth Guard EUDAMED
- Model / Reference
- TW-T001，TW-T002，TW-T003，TW-T004，TW-T005，TW-T006，TW-T007，TW-T008，TW-T009，TW-T010，TW-T011，TW-T012，TW-T013，TW-T014，TW-T015，TW-T016，TW-T017，TW-T018，TW-T019，TW-T020，or customized EUDAMEDTW-T006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939797200062 EUDAMED
- Basic UDI-DI
- 69397972MG001VN EUDAMED
- EMDN Code
- Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Mouth Guard by Fuzhou Delphin Bio-tech Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69397972MG001VN | Class I | Active |
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Manufacturer
- Manufacturer
- Fuzhou Delphin Bio-tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000050306
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 25d0868c-3bf9-4170-bfbc-b3c378dc628d 61 fields · synced Jun 19, 2026